A Radiopharmacokinetic and Radiodosimetric Phase I Imagin... | NCT00756691

Studies
A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

NCT00756691

Sponsor

AHS Cancer Control Alberta

Status

Withdrawn

Last Update Posted

Nov 14, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hypoxic Tumours

Interventions

18F-FAZA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Limited scanner availability

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 19, 2008

First Submission Date that Met QC Criteria

Sep 19, 2008

First Posted Date

Sep 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2017

Last Update Posted Date

Nov 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.

Detailed Description

A Phase I Radiopharmacokinetic and Radiodosimetric study of 18F-FAZA. Prior to treatment, subjects will receive a single injection of 18F-FAZA. Subjects will undergo a series of 5-5 PET scans, and will have 8-13 blood samples and 2 urine samples taken at specified time points over a 4.5-5.5 hour period. 18F-FAZA PET images will be reviewed to develop a dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18F-FAZA and its metabolites.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		First 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours	Other: 18F-FAZA
2		Next 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours	Other: 18F-FAZA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAZA	Other	Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient	1 2

Measure	Description	Time Frame
To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.		2 years

Measure	Description	Time Frame
To determine radiation dosimetry and optimal imaging times		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male of Female > or = to 18 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required
Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion > 1 cm in diameter
Able and willing to follow instructions and comply with the protocol
Provide written informed consent prior to participation in the study
Karnofsky Performance Scale Score of 70-100

Exclusion Criteria:

Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET
Bilirubin > or = to 200 umol/L
Creatinine > or - to 150 umol/L
AST or ALT > or = to 5 times the upper limits of normal
Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
Nursing or pregnant females

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with known primary or suspected metastatic carcinoma of the following: squamous cell carcinoma (SCC) of the head and neck, small (SCLC) and non-small cell lung cancer(NSCLC), Glioblastoma multiforme (GBM), lymphoma, or neuroendocrine tumours (NET).

Sampling Method

Non-Probability Sample